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Clinical Trials/NCT06192056
NCT06192056
Completed
N/A

Feasibility and Preliminary Efficacy of Web-Based Self-Help Program on Repetitive Negative Thinking for College Students: A Randomized Pilot Study

CanSagligi Foundation1 site in 1 country50 target enrollmentDecember 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Repetitive Negative Thinking
Sponsor
CanSagligi Foundation
Enrollment
50
Locations
1
Primary Endpoint
Change from Baseline in Perseverative Thinking Questionnaire (PTQ) Scores
Status
Completed
Last Updated
last year

Overview

Brief Summary

The goal of this pilot study is to test the feasibility and preliminary efficacy of the repetitive negative thinking (RNT) focused web-based self-help program in college students. The main questions it aims to answer are:

  • Does the program work without any help of a clinician?
  • Does the program have any reducing effect on the participants' RNT, depression, anxiety, stress and cognitive fusion scores? - Does the program help participants to improve their psychological flexibility and committed actions? Participants will be administered a set of questionnaires before and after completing the 10-day long web-based self-help program, provided on a daily basis. Researchers will compare the intervention group with a waitlist control group to assess for any potential placebo effect.

Detailed Description

After obtaining informed consent, all participants will receive a set of questionnaires for baseline measurement. Participants will be randomized into two groups using block randomization: one as the intervention group and the other as the control group (waitlist condition). This method helps ensure an equal distribution of participants with similar characteristics in both groups, minimizing potential biases and increasing the validity of the study.

Registry
clinicaltrials.gov
Start Date
December 1, 2023
End Date
December 22, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
CanSagligi Foundation
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • having internet connection and a working smart phone or computer

Exclusion Criteria

  • having thoughts of self-harm or suicide,
  • diagnosed with psychotic disorder,
  • substance abuse
  • currently receiving psychological help

Outcomes

Primary Outcomes

Change from Baseline in Perseverative Thinking Questionnaire (PTQ) Scores

Time Frame: Baseline and Week 2

The PTQ is a validated self-report instrument assessed content-independent trait-based RNT. It consists of 15 items that rated on the score of 0 (never) to 4 (almost always). The reliability and validity of the Turkish version of the scale is checked and it found suitable for Turkish population. Change (Post-intervention score- Baseline score)

Secondary Outcomes

  • Improvement in Cognitive Fusion Questionnaire (CFQ) Scores(Baseline and Week 2)
  • Increase in Committed Actions(Baseline and Week 2)
  • Change from Baseline in Depression Anxiety Stress Scale-21 (DASS-21) Scores(Baseline and Week 2)
  • System Usability Assessment(Week 2)
  • Enhancement in Psychological Flexibility measured by Acceptance and Action Questionnaire (AAQ-II)(Baseline and Week 2)

Study Sites (1)

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